STUDY OF THE EXPRESSION OF CIRCULATING AND INTRA-TUMORAL CHEMOKINES IN PATIENTS WITH PROSTATE CANCER

Prostate Cancer Clinical Trial

— CHEMOPROST  

Official title:

TUDY OF THE EXPRESSION OF CIRCULATING AND INTRA-TUMORAL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02869282
• Other study ID #: IB2011-CHEMOPROST
• Status: Recruiting
• Phase: N/A
• First received: June 28, 2016
• Last updated: August 16, 2016
• Start date: June 2011
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Institut Bergonié
• Contact: Guilhem ROUBAUD, MD
• Email: g.roubaud[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

Multicentric, observational, prospective, non-interventional study with occasional biological sample collection (serum bank, urine bank and tumor bank)

Description:

This project is an exploratory study, based on the hypothesis of involvement of chemokines in hormonal escape of prostate cancers.

The two main objectives are:

• To describe the variations in expression of chemokines in serum and urine level in patients with prostate cancer

• And to study the disease stage and intra-prostatic concentrations of chemokines based on serum and urine concentrations of chemokines before treatment initiation.

These estimates can be used in future trials set up for the management of prostate cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a localized or metastatic prostate adenocarcinoma for which a new treatment will be implemented (hormone therapy for single biological relapse or relapses and metastatic hormone-sensitive) or chemotherapy (for biological relapses and / or metastatic hormone-resistant)

• Patients with a detectable PSA (Prostate-Specific Antigen)

• Patients who signed an informed consent

• Patients over 18 years

• Patients belonging to the social security scheme

Exclusion Criteria:

• Active Hepatitis B or C virus

• HIV positive

• Patients who have received prior chemotherapy

• Patients with a second neoplasia treated in the last 5 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Blood samples
Additional blood samples at baseline, 6, 12, 18 and 24 months.
• Urine samples
Additional urine samples at baseline, 6, 12, 18 and 24 months.

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of chemokines initially detectable in the blood or urine and evolution during follow-up: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical		At baseline	No
Primary	Concentration of chemokines initially detectable in the blood or urine and evolution during follow-up: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical		At 6 months	No
Primary	Concentration of chemokines initially detectable in the blood or urine and evolution during follow-up: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical		At 12 months	No
Primary	Concentration of chemokines initially detectable in the blood or urine and evolution during follow-up: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical		At 18 months	No
Primary	Concentration of chemokines initially detectable in the blood or urine and evolution during follow-up: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical		At 24 months	No
Primary	Blood urine and prostatic concentration of chemokines at baseline: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical		At baseline	No